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FDA Approves Stemedica IND Application for Stemedyne(TM)-MSC In Cutaneous Photoaging

Posted: Published on September 28th, 2012

SAN DIEGO, Calif., Sept. 28, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the safety, tolerability and clinical effects of Stemedyne-MSC (Stemedica's human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with cutaneous photoaging resulting from overexposure to ultraviolet radiation. Curt M. Littler, M.D., F.A.A.D., dermatologist at Sharp Rees-Stealy Medical Group, Inc., is the principal investigator of the study. Dr. Littler commented, "This study is an important step forward in the field of dermatology. Photoaging is a universal condition. Damage from the sun's rays alters the skin's underlying structures, such as collagen, elastin, and blood vessels, and contributes to the creation of abnormal epidermal cells, which can become precancerous. By administering stem cells systemically, this study has the potential to target skin damage throughout the body and promises to pave the way for new treatment approaches for photoaged skin." The IND approval allows Stemedica to initiate a clinical trial at medical centers within the United States. The clinical trial will be a Phase I/IIa multi-center … Continue reading

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BioTime Forms BioTime Acquisition Corporation

Posted: Published on September 28th, 2012

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX), an Alameda-based company engaged in research and development of innovative new products in the field of regenerative medicine utilizing stem cells and related technology, announced today that it has formed a new wholly owned subsidiary, BioTime Acquisition Corporation, to pursue opportunities and acquire assets and businesses in the fields of stem cells and regenerative medicine. Thomas Okarma, PhD, MD, will serve as the Chief Executive Officer and as a member of the board of directors of BioTimes new subsidiary. Dr. Okarma is the former President and Chief Executive Officer of Geron Corporation and served on that companys board of directors. Since 2010, BioTime has expanded the scope of its business through strategic acquisitions and has been continually exploring other acquisition opportunities in its fields of interest. BioTimes strategic acquisitions include: Global advances on multiple fronts of stem cell biology have established the foundation for an integrative business approach to consolidate and translate these discoveries into products that may revolutionize clinical medicine, said Thomas Okarma, the new companys CEO. Living cell therapies can now be scalably manufactured, efficiently distributed to points of care, and tested in controlled clinical trials.The goal of regenerative medicine … Continue reading

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FDA Approves Stemedica IND Application for Stemedyne(TM)-MSC In Cutaneous Photoaging

Posted: Published on September 28th, 2012

SAN DIEGO, Calif., Sept. 28, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the safety, tolerability and clinical effects of Stemedyne-MSC (Stemedica's human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with cutaneous photoaging resulting from overexposure to ultraviolet radiation. Curt M. Littler, M.D., F.A.A.D., dermatologist at Sharp Rees-Stealy Medical Group, Inc., is the principal investigator of the study. Dr. Littler commented, "This study is an important step forward in the field of dermatology. Photoaging is a universal condition. Damage from the sun's rays alters the skin's underlying structures, such as collagen, elastin, and blood vessels, and contributes to the creation of abnormal epidermal cells, which can become precancerous. By administering stem cells systemically, this study has the potential to target skin damage throughout the body and promises to pave the way for new treatment approaches for photoaged skin." The IND approval allows Stemedica to initiate a clinical trial at medical centers within the United States. The clinical trial will be a Phase I/IIa multi-center … Continue reading

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The great stem cell dilemma

Posted: Published on September 28th, 2012

By Jeffrey M. O'Brien, contributor Stem cells stored in liquid nitrogen at Advanced Cell Technology in Marlborough, Mass. FORTUNE -- Imagine yourself the proud but rueful owner of an ancient Jaguar. Every day you dread the uncertainty that comes with trying to get from here to there -- there, more often than not, being the shop. No sooner does one ailment find repair than another appears. At best, it's a slow, uncomfortable ride. Lonely too. There's really no one around who fully understands your plight. That is how Patricia Riley describes life in a 95-year-old body. Riley, who reached that milestone birthday last St. Patrick's Day, lives alone in the same 1,100-square-foot house in Plainfield, Conn., that she's called home for 64 years, having survived her husband (heart disease), a daughter (breast cancer), and every friend she ever had. "All the people I knew have all gone, Jeffrey," she says in a quivering voice laced with melancholy. "They've all died. I go to church and I never see people my age." Her remaining family includes two daughters, five grandchildren, and eight great-grandchildren, including my two young sons. In a nod to her French-Canadian heritage, we call her Mme. Mme attributes … Continue reading

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Purging Stem Cells To Make Therapy Safer

Posted: Published on September 28th, 2012

Featured Article Academic Journal Main Category: Stem Cell Research Also Included In: Biology / Biochemistry Article Date: 28 Sep 2012 - 1:00 PDT Current ratings for: Purging Stem Cells To Make Therapy Safer 4.67 (3 votes) 5 (1 votes) The study appears in a 27 September issue of the journal Stem Cells Translational Medicine. iPS cells have properties similar to embryonic stem cells, which are "master cells" with an unlimited capacity to differentiate into any type of tissue in the body, such as brain, lung, skin, heart, and liver. Thus their potential in regenerative medicine, where damaged or diseased tissue can be repaired or replaced by growing new tissue, is huge, as senior author Timothy Nelson explains in a press release: "Pluripotent stem cells show great promise in the field of regenerative medicine; however, the risk of uncontrolled cell growth will continue to prevent their use as a therapeutic treatment." Nelson is Assistant Professor of Medicine and Pharmacology and works in the General Internal Medicine department and the Transplant Center at the Mayo. The idea of using iPS cells is for doctors to be able to take some adult tissue, for example skin cells, from the patient who needs the … Continue reading

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Cytori’s Stem Cell Therapy for Burns Wins U.S. Contract

Posted: Published on September 28th, 2012

By Ryan Flinn - 2012-09-28T16:23:41Z Cytori Therapeutics Inc. (CYTX), a biotechnology company with $10 million in annual revenue, rose the most in more than a year after the company won a $4.7 million U.S. government contract to develop a stem cell therapy to treat burns caused by thermal or radioactive bombs. Cytori jumped 19 percent to $4.58 at 12:11 p.m. New York time, after earlier reaching $4.93 for the biggest intraday increase since August 2011. The shares of the San Diego-based company rose 75 percent this year through yesterday. Were seeing a lot of momentum, Chief Executive Officer Christopher Calhoun said today in an interview with Bloomberg Television. This contract is one more major thing that we are delivering on, and there is more to come. This is an important year for us. The two-year contract with the Department of Health and Human Services Biomedical Advanced Research and Development Authority may be worth $106 million over five years if certain milestones are met, Cytori said today in a statement. The company had a net loss last year of $32 million, according to data compiled by Bloomberg. Cytoris experimental therapy takes adipose tissue, or body fat, from a patient and through … Continue reading

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Purging Stem Cells To Make Therapy Safer

Posted: Published on September 28th, 2012

Featured Article Academic Journal Main Category: Stem Cell Research Also Included In: Biology / Biochemistry Article Date: 28 Sep 2012 - 1:00 PDT Current ratings for: Purging Stem Cells To Make Therapy Safer 4.67 (3 votes) 5 (1 votes) The study appears in a 27 September issue of the journal Stem Cells Translational Medicine. iPS cells have properties similar to embryonic stem cells, which are "master cells" with an unlimited capacity to differentiate into any type of tissue in the body, such as brain, lung, skin, heart, and liver. Thus their potential in regenerative medicine, where damaged or diseased tissue can be repaired or replaced by growing new tissue, is huge, as senior author Timothy Nelson explains in a press release: "Pluripotent stem cells show great promise in the field of regenerative medicine; however, the risk of uncontrolled cell growth will continue to prevent their use as a therapeutic treatment." Nelson is Assistant Professor of Medicine and Pharmacology and works in the General Internal Medicine department and the Transplant Center at the Mayo. The idea of using iPS cells is for doctors to be able to take some adult tissue, for example skin cells, from the patient who needs the … Continue reading

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Cytori’s Stem Cell Therapy for Burns Wins U.S. Contract

Posted: Published on September 28th, 2012

By Ryan Flinn - 2012-09-28T16:23:41Z Cytori Therapeutics Inc. (CYTX), a biotechnology company with $10 million in annual revenue, rose the most in more than a year after the company won a $4.7 million U.S. government contract to develop a stem cell therapy to treat burns caused by thermal or radioactive bombs. Cytori jumped 19 percent to $4.58 at 12:11 p.m. New York time, after earlier reaching $4.93 for the biggest intraday increase since August 2011. The shares of the San Diego-based company rose 75 percent this year through yesterday. Were seeing a lot of momentum, Chief Executive Officer Christopher Calhoun said today in an interview with Bloomberg Television. This contract is one more major thing that we are delivering on, and there is more to come. This is an important year for us. The two-year contract with the Department of Health and Human Services Biomedical Advanced Research and Development Authority may be worth $106 million over five years if certain milestones are met, Cytori said today in a statement. The company had a net loss last year of $32 million, according to data compiled by Bloomberg. Cytoris experimental therapy takes adipose tissue, or body fat, from a patient and through … Continue reading

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Ottawa keeps ADHD reports secret

Posted: Published on September 28th, 2012

Health Canada has detailed records of probes into ADHD drug safety, including fatalities, that it is keeping secret from the public. Every six months to a year, drug companies submit summaries of side effects suspected to have been caused by their drugs worldwide, information Health Canada says it evaluates. These summaries, called periodic safety update reports, are not available to the public. They may contain personal or confidential business information, Health Canada said in an email to the Star. That means parents of kids taking ADHD drugs are being kept in the dark about what the makers of these drugs are revealing to Health Canada about their safety. Health Canada said the drug company reports can be requested under access to information legislation, adding details could be blacked out on a case-by-case basis if released. Health Canada is claiming privileged information? How does that trump the health of my son? said Christopher Folz, a special-education teacher from Sault Ste. Marie whose 9-year-old son tried to hurt himself while on ADHD drugs Strattera and Biphentin. Folz said his son suffered headaches last year that made him double over in pain and gag. Hes had these really troubling depressive outbursts in class … Continue reading

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Impotence, Erectile Dysfunction, Low Sex Drive, Other Propecia Side Effects May be Long-Lasting

Posted: Published on September 28th, 2012

Its becoming increasingly clear that men who use Propecia run the risk of developing severe sexual side effects, including impotence, erectile dysfunction, lower sex drive, infertility, testicular pain and genital shrinkage. Unfortunately for many men, recent research indicates that Propecia sexual side effects often continue long after they stop taking the baldness drug. Propecia belongs to a class of drugs known as 5-alpha reductase inhibitors, or 5-ARIs. The active ingredient in Propecia can interfere with male hormones, including testosterone derivatives. According to a report from the Brisbane Times, a study published in the Journal of Sexual Medicine in July found that the majority of men who report Propecia sexual side effects continued experiencing problems for at least three months after they discontinued the medication. The most common problems reported included: These Propecia sexual side effects can take a tremendous toll on the people who suffer them A second study authored by the same researcher and published in August found nearly 44 percent of 61 young, healthy Propecia patients reported suicidal thoughts, while 36 percent had symptoms of severe depression. Dr. Michael Irwig, the author of both studies, published a previous study in 2011 which also found that men using finasteride … Continue reading

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